Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms (NCT NCT02653417)

Last Updated: 2019-03-13

Results Overview

Change from baseline to week 12 in the average number of moderate and severe hot flashes per day, where change is calculated as week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency. Severity of hot flashes was self-assessed and reported as follows: * Mild: sensation of heat without sweating * Moderate: sensation of heat with sweating, able to continue activity * Severe: sensation of heat with sweating, causing cessation of activity.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

139 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2019-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Regimen 1 RAD1901 5 mg RAD1901: RAD1901	Regimen 2 RAD1901 10 mg RAD1901: RAD1901	Regimen 3 RAD1901 20 mg RAD1901: RAD1901	Regimen 4 Placebo Placebo: Placebo
Overall Study STARTED	38	34	29	38
Overall Study COMPLETED	37	32	26	33
Overall Study NOT COMPLETED	1	2	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regimen 1 RAD1901 5 mg n=38 Participants RAD1901 5 mg RAD1901: RAD1901	Regimen 2 RAD1901 10 mg n=34 Participants RAD1901 10 mg RAD1901: RAD1901	Regimen 3 RAD1901 20 mg n=28 Participants RAD1901 20 mg RAD1901: RAD1901	Regimen 4 Placebo n=38 Participants Placebo Placebo: Placebo	Total n=138 Participants Total of all reporting groups
Age, Continuous	56.6 years STANDARD_DEVIATION 4.83 • n=5 Participants	55.4 years STANDARD_DEVIATION 5.08 • n=7 Participants	54.1 years STANDARD_DEVIATION 4.07 • n=5 Participants	53.9 years STANDARD_DEVIATION 5.09 • n=4 Participants	55.1 years STANDARD_DEVIATION 4.9 • n=21 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	34 Participants n=7 Participants	28 Participants n=5 Participants	38 Participants n=4 Participants	138 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	29 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	26 Participants n=7 Participants	21 Participants n=5 Participants	32 Participants n=4 Participants	109 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	34 Participants n=21 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	22 Participants n=7 Participants	21 Participants n=5 Participants	27 Participants n=4 Participants	100 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	38 participants n=5 Participants	34 participants n=7 Participants	28 participants n=5 Participants	38 participants n=4 Participants	138 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: The modified intent to treat (mITT) population was used. This included all patients in the safety population who had recorded hot flash data in their eDiaries for at least 5 days during baseline and for at least one day while on double-blind study medication, and was the primary analysis population for all efficacy analyses

Outcome measures

Outcome measures
Measure	Regimen 1 n=38 Participants RAD1901 5 mg RAD1901: RAD1901	Regimen 2 n=34 Participants RAD1901 10 mg RAD1901: RAD1901	Regimen 3 n=28 Participants RAD1901 20 mg RAD1901: RAD1901	Regimen 4 n=38 Participants Placebo Placebo: Placebo
Change From Baseline to Week 12 in the Frequency of Moderate to Severe Hot Flashes	-3.48 moderate to severe hot flashes per day Standard Error 0.793	-3.74 moderate to severe hot flashes per day Standard Error 0.867	-4.12 moderate to severe hot flashes per day Standard Error 0.944	-3.66 moderate to severe hot flashes per day Standard Error 0.808

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: mITT population

Change from baseline to week 4 in the average number of moderate and severe hot flashes per day, where change is calculated as week 4 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency.

Outcome measures

Outcome measures
Measure	Regimen 1 n=38 Participants RAD1901 5 mg RAD1901: RAD1901	Regimen 2 n=34 Participants RAD1901 10 mg RAD1901: RAD1901	Regimen 3 n=28 Participants RAD1901 20 mg RAD1901: RAD1901	Regimen 4 n=38 Participants Placebo Placebo: Placebo
Change From Baseline to Week 4 in the Frequency of Moderate to Severe Hot Flashes	-1.15 moderate to severe hot flashes per day Standard Deviation 3.644	-2.22 moderate to severe hot flashes per day Standard Deviation 4.872	-2.70 moderate to severe hot flashes per day Standard Deviation 3.764	-3 moderate to severe hot flashes per day Standard Deviation 4.075

SECONDARY outcome

Timeframe: Baseline, 4 weeks, and 12 weeks

Population: mITT population

Change from baseline to week 4 and week 12 in the average daily severity of hot flashes, where change is calculated as week 4 or week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash severity. Subjects recorded the number of hot flashes per day using an electronic diary. Daily severity score for hot flashes for each subject was calculated as the sum of the number of mild hot flashes, plus 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of mild, moderate, and severe hot flashes. That is, Daily Severity Score = (Fmild + 2•Fmod + 3•Fsev)/(Fmild + Fmod + Fsev) where Fmild= frequency of mild hot flashes, Fmod = frequency of moderate hot flashes, Fsev = frequency of severe hot flashes. The measure is a weighted average of the frequencies of Hot Flashes.

Outcome measures

Outcome measures
Measure	Regimen 1 n=38 Participants RAD1901 5 mg RAD1901: RAD1901	Regimen 2 n=34 Participants RAD1901 10 mg RAD1901: RAD1901	Regimen 3 n=28 Participants RAD1901 20 mg RAD1901: RAD1901	Regimen 4 n=38 Participants Placebo Placebo: Placebo
Change From Baseline to Week 4 and Week 12 in the Severity of Hot Flashes Week 4 change from baseline in severity	-0.04 hot flash severity score per day Standard Deviation 0.25	-0.07 hot flash severity score per day Standard Deviation 0.26	-0.13 hot flash severity score per day Standard Deviation 0.273	-0.00 hot flash severity score per day Standard Deviation 0.280
Change From Baseline to Week 4 and Week 12 in the Severity of Hot Flashes Week 12 change from baseline in severity	-0.09 hot flash severity score per day Standard Deviation 0.337	-0.08 hot flash severity score per day Standard Deviation 0.373	-0.13 hot flash severity score per day Standard Deviation 0.313	-0.01 hot flash severity score per day Standard Deviation 0.409

SECONDARY outcome

Timeframe: Baseline, 4 weeks, and 12 weeks

Population: mITT population

Change from baseline to week 4 and week 12 in the average number of all hot flashes (mild, moderate, and severe) by eDiary, where change is calculated as week 4 or week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency.

Outcome measures

Outcome measures
Measure	Regimen 1 n=38 Participants RAD1901 5 mg RAD1901: RAD1901	Regimen 2 n=34 Participants RAD1901 10 mg RAD1901: RAD1901	Regimen 3 n=28 Participants RAD1901 20 mg RAD1901: RAD1901	Regimen 4 n=38 Participants Placebo Placebo: Placebo
Change From Baseline to Week 4 and Week 12 in the Frequency of All Hot Flashes Week 4 change from baseline	-0.99 hot flashes per day Standard Deviation 3.803	-2.23 hot flashes per day Standard Deviation 4.792	-2.29 hot flashes per day Standard Deviation 3.754	-3.27 hot flashes per day Standard Deviation 4.107
Change From Baseline to Week 4 and Week 12 in the Frequency of All Hot Flashes Week 12 change from baseline	-3.47 hot flashes per day Standard Deviation 5.076	-2.40 hot flashes per day Standard Deviation 3.560	-3.91 hot flashes per day Standard Deviation 5.263	-3.74 hot flashes per day Standard Deviation 4.228

Adverse Events

Regimen 1 RAD1901 5 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Regimen 2 RAD1901 10 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Regimen 3 RAD1901 20 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Regimen 4 Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Regimen 1 RAD1901 5 mg n=38 participants at risk RAD1901 5 mg RAD1901: RAD1901	Regimen 2 RAD1901 10 mg n=34 participants at risk RAD1901 10 mg RAD1901: RAD1901	Regimen 3 RAD1901 20 mg n=29 participants at risk RAD1901 20 mg RAD1901: RAD1901	Regimen 4 Placebo n=38 participants at risk Placebo Placebo: Placebo
Gastrointestinal disorders Nausea	2.6% 1/38 • Up to 14 weeks	0.00% 0/34 • Up to 14 weeks	0.00% 0/29 • Up to 14 weeks	10.5% 4/38 • Up to 14 weeks
Gastrointestinal disorders Diarrhoea	2.6% 1/38 • Up to 14 weeks	0.00% 0/34 • Up to 14 weeks	3.4% 1/29 • Up to 14 weeks	5.3% 2/38 • Up to 14 weeks
Gastrointestinal disorders Dyspepsia	0.00% 0/38 • Up to 14 weeks	2.9% 1/34 • Up to 14 weeks	6.9% 2/29 • Up to 14 weeks	2.6% 1/38 • Up to 14 weeks
Gastrointestinal disorders Abdominal Pain	0.00% 0/38 • Up to 14 weeks	2.9% 1/34 • Up to 14 weeks	0.00% 0/29 • Up to 14 weeks	5.3% 2/38 • Up to 14 weeks
Infections and infestations Upper respiratory tract infection	2.6% 1/38 • Up to 14 weeks	0.00% 0/34 • Up to 14 weeks	6.9% 2/29 • Up to 14 weeks	5.3% 2/38 • Up to 14 weeks
Infections and infestations Sinusitis	0.00% 0/38 • Up to 14 weeks	0.00% 0/34 • Up to 14 weeks	3.4% 1/29 • Up to 14 weeks	5.3% 2/38 • Up to 14 weeks
Reproductive system and breast disorders Vaginal haemorrhage	5.3% 2/38 • Up to 14 weeks	2.9% 1/34 • Up to 14 weeks	3.4% 1/29 • Up to 14 weeks	10.5% 4/38 • Up to 14 weeks
Nervous system disorders Headache	5.3% 2/38 • Up to 14 weeks	2.9% 1/34 • Up to 14 weeks	3.4% 1/29 • Up to 14 weeks	5.3% 2/38 • Up to 14 weeks
Musculoskeletal and connective tissue disorders Back pain	5.3% 2/38 • Up to 14 weeks	2.9% 1/34 • Up to 14 weeks	0.00% 0/29 • Up to 14 weeks	0.00% 0/38 • Up to 14 weeks
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 2/38 • Up to 14 weeks	0.00% 0/34 • Up to 14 weeks	0.00% 0/29 • Up to 14 weeks	0.00% 0/38 • Up to 14 weeks
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/38 • Up to 14 weeks	0.00% 0/34 • Up to 14 weeks	0.00% 0/29 • Up to 14 weeks	5.3% 2/38 • Up to 14 weeks
Psychiatric disorders Insomnia	5.3% 2/38 • Up to 14 weeks	0.00% 0/34 • Up to 14 weeks	0.00% 0/29 • Up to 14 weeks	0.00% 0/38 • Up to 14 weeks
General disorders Chills	0.00% 0/38 • Up to 14 weeks	0.00% 0/34 • Up to 14 weeks	0.00% 0/29 • Up to 14 weeks	5.3% 2/38 • Up to 14 weeks

Additional Information

Clinical Operations

Radius Pharmaceuticals, Inc.

Phone: 617-551-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place